Transdermal drug delivery device for delivering opioids

Abstract

Systems and methods are provided herein for transdermal delivery of an opioid. The opioids can be delivered in a decreasing dose (dose-tapering) manner to minimize withdrawal symptoms and abuse. The systems are also designed to limit a person besides the patient from receiving the drug with the transdermal delivery device. The systems can also include abuse-deterrence features that limit the ability of a patient or unauthorized user from tampering with the device to receive the active ingredient. Novel transdermal drug delivery formulations are also provided that include an opioid agonist or partial agonist and opioid antagonist which prevent the abuse of formulation.

1 . A transdermal drug delivery device comprising:
 an active pharmaceutical ingredient comprising an opioid agonist or partial opioid agonist disposed in an opioid source;   an opioid antagonist disposed in the opioid source;   a transdermal drug delivery membrane configured to contact a skin of a patient and to provide the opioid agonist to the skin of the patient;   a fluid communication pathway between the opioid source and the transdermal drug delivery membrane;   a patient engagement surface adapted to secure the transdermal drug delivery device to the skin of the patient; and   a process controller configured to control a delivery of the opioid from the opioid source to the transdermal drug delivery membrane.   
     
     
         2 . The device of  claim 1 , further comprising: a biometric identification module configured to determine a patient biometric parameter. 
     
     
         3 . The device of  claim 2 , wherein the biometric identification module includes one or more of: pulse oximeter, fingerprint scanner, heart rate sensor, ECG sensor, skin sensors, temperature sensor, blood flow sensor, impedance sensor, retina scanner, voice activation or recognition, and facial recognition system. 
     
     
         4 . The device of  claim 2 , wherein the process controller is adapted to verify the patient biometric parameter prior to delivery of the opioid agonist or partial opioid agonist. 
     
     
         5 . The device of  claim 2 , wherein the process controller is adapted to analyze a patient biological parameter to determine a symptom associated with opioid toxicity in the patient. 
     
     
         6 . The device of  claim 5 , the process controller further configured to send an alert or notification wirelessly upon detection of the symptom associated with opioid toxicity in the patient. 
     
     
         7 . The device of  claim 1 , wherein the opioid antagonist includes Naloxone, Naltrexone, Nalmefene, or Samidorphan. 
     
     
         8 . The device of  claim 1 , wherein the opioid antagonist is in a container separate from the opioid source, wherein the container is adapted to break under a tampering force to mix the opioid agonist and the opioid antagonist. 
     
     
         9 . The device of  claim 1 , wherein the opioid antagonist comprises a modified opioid antagonist. 
     
     
         10 - 14 . (canceled) 
     
     
         15 . The device of  claim 9 , wherein the modified opioid antagonist is present in nano-particles or micro-particles of a polymer or co-polymer. 
     
     
         16 . The device of  claim 15 , wherein the polymer or co-polymer includes one or more of: cyclodextrins, poly-ethylene glycol, poly lactic acid, poly glycolic acid, poly caprolactone, cellulose acetate phthalate, poly(lactic-co-glycolic acid), hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, and gelatin. 
     
     
         17 . The device of  claim 1 , wherein the opioid antagonist is encapsulated in a polymer or inclusion complexes in the form of micro and/or nanoparticles. 
     
     
         18 - 21 . (canceled) 
     
     
         22 . The device of  claim 1 , the processor further configured to provide opioid agonist or partial opioid agonist to the patient according to a drug delivery regimen. 
     
     
         23 . The device of  claim 22 , wherein the drug delivery regimen is patient-specific and preprogrammed into the transdermal drug delivery device by a healthcare provider. 
     
     
         24 - 41 . (canceled) 
     
     
         42 . The device of  claim 1 , wherein the opioid source, transdermal drug delivery membrane, fluid communication pathway, and patient engagement surface are disposed in a disposable part, wherein the process controller is disposed in a reusable part, wherein the reusable part and the disposable part are adapted to be removably engaged. 
     
     
         43 . A method of delivering an opioid agonist to a patient comprising:
 initiating a transdermal opioid delivery protocol;   providing a first dose of the opioid agonist or partial agonist to the skin of the patient from a transdermal drug delivery device, wherein the transdermal drug delivery device includes an opioid antagonist;   providing a second dose of the opioid agonist or partial agonist to the skin of the patient from the transdermal drug delivery device based on the transdermal opioid delivery profile; and   providing a third dose of the opioid agonist or partial agonist to the skin of the patient from the transdermal drug delivery device based on the transdermal opioid delivery profile.   
     
     
         44 . The method of  claim 43 , wherein the drug delivery protocol includes a plurality of opioid doses. 
     
     
         45 . The method of  claim 43 , wherein the drug delivery protocol comprises a treatment regimen with an asymptotic dose-tapering profile. 
     
     
         46 . The method of  claim 45 , wherein the asymptotic dose-tapering profile includes each opioid agonist dose decreasing over a previous opioid dose by an amount that is lower than a decrease in opioid dosage defined by the two preceding opioid agonist doses. 
     
     
         47 . The method of  claim 43 , wherein the drug delivery protocol includes a high first opioid dose and a series of decreasing opioid doses. 
     
     
         49 - 140 . (canceled)